OTC Medication Information: Medique Diphen

MEDIQUE DIPHEN- diphenhydramine hydrochloride tablet, film coated
Proficient Rx LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other respiratory allergies

runny nose
sneezing
itching nose or throat
itchy-watery eyes

Temporarily relieves these symptoms due to the common cold

runny nose
sneezing

Warnings

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one that is used on skin.

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

marked drowsiness may occur
avoid alcohol beverages
alcohol, sedatives and tranquilizers may increase the drowsiness effect
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

If pregnant or breast feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of overdose, contact a physician or poison control center immediately.

Directions

do not use more than directed

Adults and children: (12 years and older)

Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

each caplet may contain: calcium 25mg
protect from light
use by expiration date on packet
store at room temperature 59º-86ºF (15º-30ºC
tamper-evident sealed packets
do not use any opened or torn packets

Inactive ingredients

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide

* may contain

Questions or comments?

1-800- 634-7680

184R Medique Diphen Label

71205-315-06

Diphen

Hay Fever / Allergies

Fiebre del Heno / Alergias

Antihistamine • Diphenhydramine HCl 25 mg

Pull to Open

Tire Para Abrir

Antihistomine • Diphenhydramine HCl 25mg

Antihistaminico • Hidrocloruro de Difenhidramina

Empaquetado con Sellado Evidente en Dosis Unitarias

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

71205-315-06
(click image for full-size original)
MEDIQUE DIPHEN
diphenhydramine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-315(NDC:47682-184)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color pink (pink) Score no score
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code 061;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-315-02 2 TABLET, FILM COATED in 1 PACKET None
2 NDC:71205-315-06 6 TABLET, FILM COATED in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/01/2012
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-315), RELABEL (71205-315)

Revised: 01/2021 Proficient Rx LP

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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